Administration of Kisspeptin in Patients With Hyperprolactinemia

Hypogonadism Clinical Trial

Official title:

Administration of Kisspeptin in Patients With Hyperprolactinemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02956447
• Other study ID #: 2016P002281
• Secondary ID: FD-R-5712
• Status: Completed
• Phase: Phase 2
• Start date: November 17, 2017
• Est. completion date: July 29, 2023

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to learn more about how kisspeptin, a naturally occurring hormone, affects women with high levels of prolactin (also called hyperprolactinemia). All participants will receive kisspeptin in a pulsatile fashion. Subjects in one group will attend two 12-hour visits with frequent blood draws. Subjects in the second group will wear a pump that administers kisspeptin subcutaneously (SC) over eight days and attend seven short blood sampling visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 29, 2023
• Est. primary completion date: June 28, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion/Exclusion Criteria:

• confirmed diagnosis of elevated levels of prolactin measured via blood test,
• no pituitary adenoma OR a microprolactinoma (<10 mm). Patients with a macroprolactinoma confirmed on MRI imaging will be excluded,
• no history of a medication reaction requiring emergency medical care,
• no illicit drug use or excessive alcohol consumption (>10 drinks/week),
• not currently seeking fertility, breastfeeding or pregnant,
• no history of bilateral oophorectomy,
• willing to complete a dopamine agonist washout and/or oral contraceptive washout,
• normal physical exam and laboratory studies within protocol reference range.

Related Conditions & MeSH terms

• Hyperprolactinemia
• Hypogonadism

Intervention

Drug:
• Kisspeptin 112-121
0.313 ug/kg IV or 0.313 ug/kg - 13.19 ug/kg SC
• GnRH
0.075 ug/kg IV

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average change in number of luteinizing hormone (LH) pulse frequency (Kisspeptin Bolus and Baseline Sampling arm)	Average change in LH pulse frequency at baseline and during kisspeptin IV administration	Up to 23 days
Primary	Change in follicle size in mm by ultrasound (Pulsatile Kisspeptin arm)	Change in follicle size in mm by ultrasound over the course of SC kisspeptin administration	Evaluated over eight days
Secondary	Average change in LH pulse amplitude (Kisspeptin Bolus and Baseline Sampling arm)	Average change in LH pulse amplitude at baseline and during kisspeptin administration	Up to 23 days